Development of Gastrointestinal Symptoms in Patients With Anorexia Nervosa and Bulimia Nervosa During Weight Rehabilitation Over Time, Depending on the Nutritional Strategy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 185
- 试验地点
- 1
- 主要终点
- Gastrointestinal Symptoms
研究概览
简要总结
This prospective observational study investigates the development of gastrointestinal (GI) symptoms in patients with anorexia nervosa (AN) and bulimia nervosa (BN) during multi-week inpatient weight rehabilitation. The study explores how the predominant nutritional strategy-flexitarian, vegetarian, or vegan-relates to changes in GI symptoms over the course of treatment. In addition to diet, the study examines how weight gain and other clinical, psychological, and demographic factors influence the trajectory of GI symptoms. Patients complete weekly questionnaires assessing GI symptoms as part of routine care at the Eating Disorder Center of the Klinik Lüneburger Heide, Germany. Further data are drawn from standard clinical assessments, including body weight, body composition, and psychometric instruments. The primary outcome is the change in GI symptom severity (measured via the GSRS score) from admission to discharge, analyzed in relation to dietary pattern and weight development. Secondary analyses will explore symptom progression over time, group differences between AN and BN, and predictors of GI symptom improvement, including dietary intake, baseline psychological status, symptom change, weight trajectory, and treatment duration. The outcomes will be analyzed separately for AN and BN. The study aims to recruit approximately 150 patients with AN and 35-40 with BN. Inclusion requires a diagnosis of AN (any subtype) or BN, age over 12 years, clinical stability, and the ability to provide informed consent. The findings aim to inform evidence-based dietary recommendations for individuals with eating disorders who experience significant GI symptoms during nutritional rehabilitation.
详细描述
This prospective observational study investigates the development of gastrointestinal (GI) symptoms in patients with anorexia nervosa (AN) and bulimia nervosa (BN) during multi-week inpatient weight rehabilitation. The study explores how the predominant nutritional strategy-flexitarian, vegetarian, or vegan-relates to changes in GI symptoms over the course of treatment. In addition to diet, the study examines how weight gain and other clinical, psychological, and demographic factors influence the trajectory of GI symptoms. Patients complete weekly questionnaires assessing GI symptoms as part of routine care at the Eating Disorder Center of the Klinik Lüneburger Heide, Germany. Further data are drawn from standard clinical assessments, including body weight, body composition, and psychometric instruments. The primary outcome is the change in GI symptom severity (measured via the GSRS score) from admission to discharge, analyzed in relation to dietary pattern and weight development. Secondary analyses will explore symptom progression over time, group differences between AN and BN, and predictors of GI symptom improvement, including dietary intake, baseline psychological status, symptom change, weight trajectory, and treatment duration. The study aims to recruit approximately 150 patients with AN and 35-40 with BN. Inclusion requires a diagnosis of AN (any subtype) or BN, age over 12 years, clinical stability, and the ability to provide informed consent. The findings aim to inform evidence-based dietary recommendations for individuals with eating disorders who experience significant GI symptoms during nutritional rehabilitation.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients diagnosed with anorexia nervosa (all subtypes)
- •patients diagnosed bulimia nervosa
排除标准
- •patients that are medically unable to fill out a short questionnaire on a weekly base.
结局指标
主要结局
Gastrointestinal Symptoms
时间窗: Data are collected within the first three days after admission and during the final three days before discharge (two time points).
Score of the Gastrointestinal Symptom Rating Scale assessed upon admission and discharge (two time points), in relation to the predominant dietary pattern (\>80% during the rehabilitation phase), defined as flexitarian, vegetarian, or vegan and body weight development. The Gastrointestinal Symptom Rating Scale is a validated questionnaire : Svedlund J, Sjödin I, Dotevall G. GSRS--a clinical rating scale for gastrointestinal symptoms in patients with irritable bowel syndrome and peptic ulcer disease. Dig Dis Sci. (1988) 33(2):129-34. doi: 10.1007/BF01535722. The primary outcome is analyzed seperately for patients with anorexia nervosa and bulimia nervosa.
次要结局
- Gastrointestinal Symptoms in the Timecourse(Data are continuously collected from admission to discharge. Extraction occurs on the first three days of admission, weekly during the stay (on Mondays or Tuesdays, covering the preceding week), and on the final three days of discharge.)
- Dietary intake(Data are continuously collected throughout the inpatient stay. Extraction takes place on the day of admission, weekly during the stay (on Mondays or Tuesdays, reflecting the data of the preceding week), and on the day of discharge.)
- Body weight(Data are continuously collected from admission to discharge. Extraction occurs the second day in the morning after admission, weekly during the stay (on Mondays or Tuesdays), and at the day of discharge)
- Body height(Body weight is measured within the first two days after admission and again within the final two days prior to discharge. For inpatient stays exceeding three months, weight measurements are repeated at three-month intervals.)
- Body composition(Body composition is measured within the first two days after admission and again within the final two days prior to discharge. The outcome is analyzed seperately for patients with anorexia nervosa and bulimia nervosa.)
- Eating Disorder Inventory-2 (EDI-2)(Data are collected within the first three days after admission and during the final three days before discharge (two time points).)
- Three Factor Eating Questionnaire (TFEQ)(Data are collected within the first three days after admission and during the final three days before discharge (two time points).)
- Symptom-Checkliste (SCL-90-R)(Data are collected within the first three days after admission and during the final three days before discharge (two time points).)
- Beck-Depressions-Inventar Revision (BDI-II)(Data are collected within the first three days after admission and during the final three days before discharge (two time points).)
- Obsessive Compulsive Inventory - Revised (OCI-R)(Data are collected within the first three days after admission and during the final three days before discharge (two time points).)
- Generalizied Anxiety Disorder Scale-7 (GAD-7)(Data are collected within the first three days after admission and during the final three days before discharge (two time points).)
- Wender Utah Rating Scale (WURS-K)(Data are collected within the first three days after admission and during the final three days before discharge (two time points).)
- Subthreshold Autism Trait Questionnaire (SATQ)(Data are collected within the first three days after admission and during the final three days before discharge (two time points).)
- Frost Multidi-mensional Perfectionism Scale (FMPS)(Data are collected within the first three days after admission and during the final three days before discharge (two time points).)
- Perceived Stress Questionnaire (PSQ)(Data are collected within the first three days after admission and during the final three days before discharge (two time points).)
- Age(This is assessed upon admission.)
- Complete Blood Count (CBC) with Differential(Data will be analyzed from samples collected within the first 3 days after hospital admission, weekly throughout the inpatient stay (on or around Day 7, Day 14, etc.), and within the final 3 days prior to discharge.)
- Key electrolyte panel for fluid balance, neuromuscular function, and metabolic regulation(Data will be analyzed from samples collected within the first 3 days after hospital admission, weekly throughout the inpatient stay (on or around Day 7, Day 14, etc.), and within the final 3 days prior to discharge.)
- Liver Function Panel(Data will be analyzed from samples collected within the first 3 days after hospital admission, weekly throughout the inpatient stay (on or around Day 7, Day 14, etc.), and within the final 3 days prior to discharge.)
- Renal Function Panel(Data will be analyzed from samples collected within the first 3 days after hospital admission, weekly throughout the inpatient stay (on or around Day 7, Day 14, etc.), and within the final 3 days prior to discharge.)
- Medication Use(Data will be analyzed from samples collected within the first 3 days after hospital admission, weekly throughout the inpatient stay (on or around Day 7, Day 14, etc.), and within the final 3 days prior to discharge.)